the president's commission on combating drug ... - Whitehouse.gov

THE PRESIDENT’S COMMISSION ON COMBATING DRUG ADDICTION AND THE OPIOID CRISIS Roster of Commissioners Governor Chris Christie, Chairman Governor Charlie Baker Governor Roy Cooper Congressman Patrick J. Kennedy Professor Bertha Madras, Ph.D. Florida Attorney General Pam Bondi

Table of Contents Chairman’s Letter…………………………………………………………………………………5 Summary of Recommendations .................................................................................................... 12 The Drug Addiction and Opioid Crisis ......................................................................................... 19 Origins of the Current Crisis ..................................................................................................... 19 Magnitude and Demographics .................................................................................................. 23 Newly Emerging Threats .......................................................................................................... 26 Pathways to Opioid Use Disorder (Including Heroin) from Prescription Opioids ................... 27 Health, Financial, and Social Consequences ............................................................................. 29 Drug Overdose Deaths .............................................................................................................. 31 Substance Use Treatment Availability ...................................................................................... 32 Systems Approach to Solutions ................................................................................................ 35 Federal Funding and Programs ..................................................................................................... 37 Streamlining Federal Funding for Opioids and Consideration of State Administrators ........... 37 Funding Effective Opioid-Related Programs ............................................................................ 38 Opioid Addiction Prevention ........................................................................................................ 40 Evidence-based Prevention Programs ....................................................................................... 42 SBIRT as a School Prevention Strategy ................................................................................ 43 Mass Media Public Education Campaigns ................................................................................ 44 Media Campaign Focusing on Opioids ................................................................................. 46 Opioid Prescription Practices .................................................................................................... 48 Improving upon the CDC Guideline for Prescribing Opioids for Chronic Pain and Provider/Prescriber Education ............................................................................................... 48 Enhancing Prescription Drug Monitoring Programs (PDMP) .............................................. 53 Prescription Take-Back Programs and Drug Disposal .......................................................... 55 Pain Level as an HHS Evaluation Criteria ................................................................................ 56 Reimbursement for Non-Opioid Pain Treatments .................................................................... 57 Reducing and Addressing the Availability of Illicit Opioids .................................................... 58 Improving Data Collection and Analytics ............................................................................. 58 Disrupting the Illicit Fentanyl Supply ................................................................................... 61 Interdiction and Detection Challenges .................................................................................. 63 Protecting First Responders from Harmful Effects Resulting from Exposure to Fentanyl and other Synthetic Opioids ......................................................................................................... 65

Opioid Addiction Treatment, Overdose Reversal, and Recovery................................................. 67 Drug Addiction Treatment Services .......................................................................................... 67 Increase Screenings and Referrals to Treatment through CMS Quality Measures ............... 67 Evidence-based Improvements to Treatment ........................................................................ 68 Insurance and Reimbursement Barriers to Accessing MAT ................................................. 69 Enforcing the Mental Health Parity and Addiction Equity Act (MHPAEA) ........................ 71 MAT in the Criminal Justice System .................................................................................... 72 Drug Courts and Diversion Programs ................................................................................... 73 Addiction Services Workforce and Training Needs .............................................................. 74 Response to Overdose ............................................................................................................... 77 Expanded Access and Administration of Naloxone .............................................................. 77 Overdose to Treatment and Recovery ................................................................................... 79 Recovery Support Services ....................................................................................................... 80 Impact on Families and Children........................................................................................... 80 Supporting Collegiate Recovery and Changing the Culture on College Campuses.............. 81 Employment Opportunities for Americans in Recovery ....................................................... 83 Support Recovery Housing.................................................................................................... 84 Research & Development ............................................................................................................. 86 New Pain, Overdose, and MAT Medications ........................................................................... 86 Medical Technology Devices .................................................................................................... 88 FDA Post-Market Research and Surveillance Programs .......................................................... 89 Conclusion .................................................................................................................................... 90 Current Federal Programs and Funding Landscape ...................................................................... 93 Overview ................................................................................................................................... 93 FY 2018 Funding Specific to America’s Opioid Crisis ............................................................ 93 The Comprehensive Addiction and Recovery Act (CARA) ................................................. 96 21st Century Cures Act .......................................................................................................... 96 FY 2018 Consolidated Federal Drug Control Budget ............................................................... 97 Prevention .............................................................................................................................. 97 Treatment and Recovery........................................................................................................ 98 Domestic Law Enforcement ................................................................................................ 101 Interdiction........................................................................................................................... 102 International Efforts ............................................................................................................. 103 3

Charter, President’s Commission on Combating Drug Addiction and the Opioid Crisis .......... 107 Appendices .................................................................................................................................. 110 Appendix 1. Acronyms .......................................................................................................... 110 Appendix 2. History of Opiate Use and Abuse ...................................................................... 113 Appendix 3. Interim Report, President’s Commission on Combatting Drug Addiction and the Opioid Crisis ........................................................................................................................... 115 Appendix 4. Fentanyl Safety Recommendations for First Responders ................................. 125 References ................................................................................................................................... 126

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O N C OMB AT IN G D RUG A DDIC TI ON A ND T HE O PIOI D C RISIS

Governor Chris Christie Chairman Governor Charlie Baker Congressman Patrick J. Kennedy

Florida Attorney General Pam Bondi

Governor Roy Cooper Professor Bertha Madras, Ph.D.

November 1, 2017 The Honorable Donald J. Trump President of the United States The White House 1600 Pennsylvania Avenue NW Washington, DC 20500 Dear President Trump, On behalf of the President’s Commission on Combating Drug Addiction and the Opioid Crisis, we thank you for entrusting us with the responsibility of developing recommendations to combat the addiction crisis that is rampantly impacting our country. Your speech in the East Room of the White House, along with the remarks of the First Lady, made it clear to the country that fighting this epidemic is a top priority of your Administration. On behalf of the Commission, we thank you for your leadership on this issue and on the clarity of your call to action. When you declared the opioid crisis a national public health emergency under federal law on October 26, 2017, you acknowledged this crisis as one of epic proportion, impacting nearly every community across all 50 states. You signaled to the country that the force of the federal government should and will mobilize to reverse the rising tide of overdose deaths. You gave the millions of Americans fighting addiction hope that we can overcome this crisis, and we are prepared to win the fight. Mr. President, as you acknowledged when you addressed the nation last week, the reason behind the urgent recommendations presented to you today by this Commission is that the leading cause of unintentional death in the United States is now drug overdose deaths. Our people are dying. More than 175 lives lost every day. If a terrorist organization was killing 175 Americans a day on American soil, what would we do to stop them? We would do anything and everything. We must do the same to stop the dying caused from within. I know you will. Without comprehensive action, including your national public health emergency, the death count will continue to rise. I know that is unacceptable to you. I know you will win this fight for the people who elected you.

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You’ve met hundreds of parents who have buried their children, so these numbers are no longer simply statistics. Instead, they represent the injured student-athlete who becomes addicted after first prescription, ending her academic and athletic career, the newborn infant who is red and screaming from withdrawal pain, the grandparents using their retirement savings to raise young kids when the parents can’t, the mom who just buried her only son, and the addict who cycles in and out of jail, simply because without access to treatment he is unable to stay sober and meet the terms of his parole. It is time we all say what we know is true: addiction is a disease. However, we do not treat addiction in this country like we treat other diseases. Neither government nor the private sector has committed the support necessary for research, prevention, and treatment like we do for other diseases. The recommendations herein, and the interim recommendations submitted by the Commission in July, are designed to address this national priority. These recommendations will help doctors, addiction treatment providers, parents, schools, patients, faith-based leaders, law enforcement, insurers, the medical industry, and researchers fight opioid abuse and misuse by reducing federal barriers and increasing support to effective programs and innovation. Obviously, many of the recommendations that follow will require appropriations from Congress into the Public Health Emergency Fund, for block grants to states and to DOJ for enforcement and judicial improvements. It is not the Commission’s charge to quantify the amount of these resources, so we do not do so in this report. You have made fighting the opioid epidemic a national priority, Mr. President. And, the country is ready to follow your lead. Now, we urge Congress to do their constitutionally delegated duty and appropriate sufficient funds (as soon as possible) to implement the Commission's recommendations. 175 Americans are dying a day. Congress must act. Here is what your Administration has already done: •

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You acted to remove one of the biggest federal barriers to treatment by announcing the launch of a new policy to overcome the restrictive, decades-old federal rule that prevents states from providing more access to care at treatment facilities with more than 16 beds. This action will take people in crisis off waiting lists where they are at risk of losing their battle to their disease and put them into a treatment bed and on the path to recovery. We urge all Governors to apply to CMS for a waiver. This policy will – without any doubt – save lives. Governors across this nation thank you for listening to our call for help. In the interim report, the Commission also called for prescriber education and enhanced access to medication-assisted treatment for those already suffering from addiction. You acknowledged the need for these recommendations and directed all federally employed prescribers to receive special training to fight this epidemic. This is a bold step by you to deal with this issue. We recommended that the Department of Justice, which has already acted forcefully to stop the flow of illicit synthetic drugs into this country through the U.S. Postal Service, 6

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continue its efforts. The aggressive enforcement action being taken by your Administration is critical in our efforts to reduce the rise of overdose deaths in this country. National Institutes of Health (NIH) Director Dr. Francis Collins has been partnering with pharmaceutical companies to develop non-addictive painkillers and new treatments for addiction and overdose. The Commission worked with Dr. Collins to convene a meeting with industry leadership to discuss innovative ways to combat the opioid crisis. The Commission also held a public meeting to highlight the progress and innovation occurring today resulting from the NIH’s work. This type of scientific progress is a positive step to help free the next generation from the widespread suffering addiction is causing today.

Our interim recommendations called for more data sharing among state-based prescription drug monitoring programs and recognized the need to address patient privacy regulations that make it difficult for health providers to access information and make informed healthcare decisions for someone who has a substance use disorder. We recommended that all law enforcement officers across the country be equipped with life-saving naloxone. Finally, we recommended full enforcement of the Mental Health Parity and Addiction Equity Act to ensure that health plans cannot provide less favorable benefits for mental health and substance use diagnoses than physical health ailments. You will see further recommendations in our final report regarding the Parity Act and calling for the Department of Labor to have enhanced penalty and enforcement powers directly against insurers failing those who depend on them for life-saving treatment. All the interim recommendations remain extremely relevant today and are critical tools to reduce ever increasing overdose deaths plaguing our citizens. The Commission is grateful the Administration has begun the hard work of implementing these initiatives. We urge you to implement the others as soon as possible. Today, the Commission, as one its most urgent recommendations among the more than 50 provided in the final report, is calling for an expansive national multi-media campaign to fight this national health emergency. This campaign, including aggressive television and social media outreach, must focus on telling our children of the dangers of these drugs and addiction, and on removing stigma as a barrier to treatment by emphasizing that addiction is not a moral failing, but rather a chronic brain disease with evidence-based treatment options. People need to be aware of the health risks associated with opioid use, and they must stop being afraid or ashamed of seeking help when facing their addiction. Today, only 10.6% of youth and adults who need treatment for a substance use disorder receive that treatment. This is unacceptable. Too many people who could be helped are falling through the cracks and losing their lives as a result. Many states, including my State of New Jersey, have undertaken this media strategy with significant positive results. However, having a nation-wide campaign will serve to reinforce the message and ensure, for example, that youth and young adults no longer believe that experimenting with pills from a doctor is safer than experimenting with illegal substances from a drug dealer. As part of its prevention recommendations, the Commission also calls for better educating 7

middle school, high school, and college students with the help of trained professionals such as nurses and counselors who can assess at-risk kids. Children have not escaped the consequences of addiction and our efforts to reduce overdose deaths must start early. Mrs. Trump’s dedication and leadership in helping our nation’s children will make this a top priority and help save innocent young lives. One of the most important recommendations in this final report is getting federal funding support more quickly and effectively to state governments, who are on the front lines of fighting this addiction battle every day. Bureaucracy, departmental silos, and red tape must not be accepted as the norm when dealing with funding to combat this epidemic. Saving time and resources, in this instance, will literally save lives. Accordingly, we are urging Congress and the Administration to block grant federal funding for opioid-related and SUD-related activities to the states. There are multiple federal agencies and multiple grants within those agencies that cause states a significant administrative burden from an application and reporting perspective. Money is being wasted and accountability for results is not as intense as it should be. Block granting them would allow more resources to be spent on administering life-saving programs. This was a request to the Commission by nearly every Governor, regardless of party, across the country. And as a Commission that has three governors as members, all of whom know the frustration of jumping through multiple hoops to receive the funding we need to help our constituents in this fight, we wholeheartedly agree. Throughout the comprehensive recommendations of its final report, the Commission also identifies the need to focus on, deploy and assess evidence-based programs that can be funded through these proposed block grants. Many of the recommendations acknowledge a need for better data analysis and accountability to ensure that any critical dollars are spent on what works best to fight this disease. From its review of the federal budget aimed at addressing the opioid epidemic, the Commission identified a disturbing trend in federal health care reimbursement policies that incentivizes the wide-spread prescribing of opioids and limits access to other non-addictive treatments for pain, as well as addiction treatment and medication-assisted treatment. First, individuals with acute or chronic pain must have access to non-opioid pain management options. Everything from physical therapy, to non-opioid medications, should be easily accessible as an alternative to opioids. The Commission heard from many innovative life sciences firms with new and promising products to treat patients’ pain in non-addictive, safer ways; but they have trouble competing with cheap, generic opioids that are so widely used. We should incentivize insurers and the government to pay for non-opioid treatments for pain beginning right in the operating room and at every treatment step along the way. In some cases, non-addictive pain medications are bundled in federal reimbursement policies so that hospitals and doctors are essentially not covered to prescribe non-opioid pain management alternatives. These types of policies, which the federal government can fix, are a significant deterrent to turning the tide on the health crisis we are facing. We urge you to order HHS to fix it.

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Second, as a condition of full reimbursement of hospitals, CMS requires that hospitals randomly survey discharged patients. HHS previously included pain question response information in calculations of incentive payment, but in 2017 thankfully abandoned this practice. However, all pain survey questions were not withdrawn from the surveys. The Commission recommends that CMS remove pain questions entirely when assessing consumers so that providers won’t ever use opioids inappropriately to raise their survey scores. We urge you to order HHS to do this immediately. The expectation of eliminating a patient’s pain as an indication of successful treatment, and seeing pain as the fifth vital sign, which has been stated by some medical professionals as unique to the United States, was cited as a core cause of the culture of overprescribing in this country that led to the current health crisis. This must end immediately. The Department of Labor must be given the real authority to regulate the health insurance industry. The health insurers are not following the federal law requiring parity in the reimbursement for mental health and addiction. They must be held responsible. The Secretary of Labor testified he needs the ability to fine violators and to individually investigate insurers not just employers. We agree with Secretary Acosta. If we do not get Congress to give him these tools, we will be failing our mission as badly as health insurance companies are failing their subscribers on this issue today leading to deaths. Also contributing to this problem is the fact that HHS/CMS, the Indian Health Service, Tricare, and the VA still have reimbursement barriers to substance abuse treatment, including limiting access to certain FDA-approved medication-assisted treatment, counseling, and inpatient/residential treatment. It’s imperative that federal treatment providers lead the way to treating addiction as a disease and remove these barriers. Each of these primary care providers employed by the abovementioned federal health systems should screen for SUDs and, directly or through referral, provide treatment within 24-to-48 hours. Each physician employee should be able to prescribe buprenorphine (if that is the most appropriate treatment for the patient) in primary care settings. As President, you can make this happen immediately. We urge you to do so. A good example of this federal leadership occurred when Department of Veterans Affairs Secretary Shulkin, in response to the Commission’s interim report release, immediately launched eight best practices for pain management in the VA health-care system. These guidelines included everything from alternatives and complimentary care, counseling and patient monitoring to peer education for front-line providers, informed consent of patients and naloxone distribution for Veterans on long-term opioid therapy. I had the opportunity to visit with doctors and patients at the Louis Stokes Northeast Ohio VA Healthcare System and witnessed first-hand the positive results of a hospital that has embraced a different continuum of care for pain management. The VA doctors, which included behavioral health specialists, acknowledge and treat those with addiction in the full complement of ways the medical community would tackle other chronic diseases. Let’s use these VA practices as an example for our entire healthcare system. As you will see in the Commission’s recommendations, the Federal Government has a number of avenues through which it can ensure that individuals with addiction disorders get the 9

help they need; including changing CMS reimbursement policies, enforcing parity laws against non-compliant insurers, promoting access to rural communities through such tools as telemedicine, and incenting a larger treatment workforce to address the broad scope of the crisis. For individuals with a substance use disorder, ensuring life-saving access to affordable health care benefits is an essential tool in fighting the opioid epidemic. Look at Indiana as an example. After Indiana used an insurance access program to rapidly respond to a rural, opioidrelated health crisis, the Indiana Department of Health reported that such a program opened the door to life changing medical treatment. We are recommending that a drug court be established in every one of the 93 federal district courts in America. It is working in our states and can work in our federal system to help treat those who need it and lower the federal prison population. For many people, being arrested and sent to a drug court is what saved their lives, allowed them to get treatment, and gave them a second chance. Drug Courts are known to be significantly more effective than incarceration, but 44% of U.S. Counties do not have an adult drug court. DOJ should urge states to establish state drug courts in every county. When individuals violate the terms of probation or parole with substance use, they need to be diverted to drug court, rather than back to incarceration. Further, drug courts need to embrace the use of medication-assisted treatment for their populations, as it clearly improves outcomes. The criminal justice system should accept that medication, when clinically appropriate, can lead to lasting recovery; abstinence-only sobriety is not the only path to recovery. Lastly, the Commission’s recommendations identify multiple ways to reduce the supply of licit and illicit opioids and enhanced enforcement strategies. Recognizing the growing threat of synthetic opioids such as fentanyl, the Commission recommends enhanced penalties for trafficking of fentanyl and fentanyl analogues and calls for additional technologies and drug detection methods to expand efforts to intercept fentanyl before entering the country. To help protect first responders, who are also on the front lines fighting this epidemic responding to overdoses sometimes multiple times a day, the Commission recommends the White House develop a national outreach strategy coordinating with Governors for the release and adoption of the Office of Homeland Security National Security Council’s new Fentanyl Safety Recommendations for First Responders. The Commission thanks White House Homeland Security Advisor Tom Bossert for his support and hard work already on this initiative. Many other thoughtful, vital recommendations are included herein. These recommendations were informed by expert testimony provided during the Commission’s public meetings, which included treatment providers and experts, pharmaceutical innovators and insurers. They also were informed by thousands of written submissions accepted by the Commission as part of its public process. The Commission acknowledges that there is an active movement to promote the use of marijuana as an alternative medication for chronic pain and as a treatment for opioid addiction. Recent research out of the NIH’s National Institute on Drug Abuse found that marijuana use led to a 2 ½ times greater chance that the marijuana user would become an opioid user and abuser. 10

The Commission found this very disturbing. There is a lack of sophisticated outcome data on dose, potency, and abuse potential for marijuana. This mirrors the lack of data in the 1990’s and early 2000’s when opioid prescribing multiplied across health care settings and led to the current epidemic of abuse, misuse and addiction. The Commission urges that the same mistake is not made with the uninformed rush to put another drug legally on the market in the midst of an overdose epidemic. The Commission extends our sincere gratitude to all of the individuals, organizations, families, companies, state officials, federal agency staff, and clinical professionals who provided personal stories, creative solutions, and thoughtful input to the Commission. The Commission members received thousands of letters, took hundreds of phone calls and meetings, and heard testimony from prominent organizations including non-profits, professional societies, pharmaceutical companies, health insurance providers, and most importantly, individuals and families that have been in the throes of addiction. These letters, conversations, and meetings were the impetus for the vast majority of recommendations made in this report. The Commission is confident that, if enacted quickly, these recommendations will strengthen the federal government, state, and local response to this crisis. But it will take all invested parties to step up and play a role: the federal executive branch, Congress, states, the pharmaceutical industry, doctors, pharmacists, academia, and insurers. The responsibility is all of ours. We must come together for the collective good and acknowledge that this disease requires a coordinated and comprehensive attack from all of us. The time to wait is over. The time for talk is passed. 175 deaths a day can no longer be tolerated. We know that you will not stand by; we believe you will force action. Along with my fellow Commission members, and the thousands of people who contributed to this report by sharing their stories and ideas for solutions, I look forward to seeing these policy changes implemented. Thank you again for the opportunity to serve, and most of all thank you for your commitment to addressing this vital national public health emergency. Sincerely,

Governor Chris Christie Governor of New Jersey Chairman, President’s Commission on Combating Drug Addiction and the Opioid Crisis

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Summary of Recommendations Federal Funding and Programs 1. The Commission urges Congress and the Administration to block grant federal funding for opioid-related and SUD-related activities to the states, where the battle is happening every day. There are multiple federal agencies and multiple grants within those agencies that cause states a significant administrative burden from an application and reporting perspective. Creating uniform block grants would allow more resources to be spent on administering life-saving programs. This was a request to the Commission by nearly every Governor, regardless of party, across the country. 2. The Commission believes that ONDCP must establish a coordinated system for tracking all federally-funded initiatives, through support from HHS and DOJ. If we are to invest in combating this epidemic, we must invest in only those programs that achieve quantifiable goals and metrics. We are operating blindly today; ONDCP must establish a system of tracking and accountability. 3. To achieve accountability in federal programs, the Commission recommends that ONDCP review is a component of every federal program and that necessary funding is provided for implementation. Cooperation by federal agencies and the states must be mandated.

Opioid Addiction Prevention 4. The Commission recommends that Department of Education (DOE) collaborate with states on student assessment programs such as Screening, Brief Intervention and Referral to Treatment (SBIRT). SBIRT is a program that uses a screening tool by trained staff to identify at-risk youth who may need treatment. This should be deployed for adolescents in middle school, high school and college levels. This is a significant prevention tool. 5. The Commission recommends the Administration fund and collaborate with private sector and non-profit partners to design and implement a wide-reaching, national multi-platform media campaign addressing the hazards of substance use, the danger of opioids, and stigma. A similar mass media/educational campaign was launched during the AIDs public health crisis. Prescribing Guidelines, Regulations, Education 6. The Commission recommends HHS, the Department of Labor (DOL), VA/DOD, FDA, and ONDCP work with stakeholders to develop model statutes, regulations, and policies that ensure informed patient consent prior to an opioid prescription for chronic pain. Patients need to understand the risks, benefits and alternatives to taking opioids. This is not the standard today. 7. The Commission recommends that HHS coordinate the development of a national curriculum and standard of care for opioid prescribers. An updated set of guidelines for prescription pain medications should be established by an expert committee composed of various specialty 12

practices to supplement the CDC guideline that are specifically targeted to primary care physicians. 8. The Commission recommends that federal agencies work to collect participation data. Data on prescribing patterns should be matched with participation in continuing medical education data to determine program effectiveness and such analytics shared with clinicians and stakeholders such as state licensing boards. 9. The Commission recommends that the Administration develop a model training program to be disseminated to all levels of medical education (including all prescribers) on screening for substance use and mental health status to identify at risk patients. 10. The Commission recommends the Administration work with Congress to amend the Controlled Substances Act to allow the DEA to require that all prescribers desiring to be relicensed to prescribe opioids show participation in an approved continuing medical education program on opioid prescribing. 11. The Commission recommends that HHS, DOJ/DEA, ONDCP, and pharmacy associations train pharmacists on best practices to evaluate legitimacy of opioid prescriptions, and not penalize pharmacists for denying inappropriate prescriptions. PDMP Enhancements 12. The Commission recommends the Administration's support of the Prescription Drug Monitoring (PDMP) Act to mandate states that receive grant funds to comply with PDMP requirements, including data sharing. This Act directs DOJ to fund the establishment and maintenance of a data-sharing hub. 13. The Commission recommends federal agencies mandate PDMP checks, and consider amending requirements under the Emergency Medical Treatment and Labor Act (EMTALA), which requires hospitals to screen and stabilize patients in an emergency department, regardless of insurance status or ability to pay. 14. The Commission recommends that PDMP data integration with electronic health records, overdose episodes, and SUD-related decision support tools for providers is necessary to increase effectiveness. 15. The Commission recommends ONDCP and DEA increase electronic prescribing to prevent diversion and forgery. The DEA should revise regulations regarding electronic prescribing for controlled substances. 16. The Commission recommends that the Federal Government work with states to remove legal barriers and ensure PDMPs incorporate available overdose/naloxone deployment data, including the Department of Transportation’s (DOT) Emergency Medical Technician (EMT) overdose database. It is necessary to have overdose data/naloxone deployment data in the PDMP to allow users of the PDMP to assist patients.

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Supply Reduction and Enforcement Strategies 17. The Commission recommends community-based stakeholders utilize Take Back Day to inform the public about drug screening and treatment services. The Commission encourages more hospitals/clinics and retail pharmacies to become year-round authorized collectors and explore the use of drug deactivation bags. 18. The Commission recommends that CMS remove pain survey questions entirely on patient satisfaction surveys, so that providers are never incentivized for offering opioids to raise their survey score. ONDCP and HHS should establish a policy to prevent hospital administrators from using patient ratings from CMS surveys improperly. 19. The Commission recommends CMS review and modify rate-setting policies that discourage the use of non-opioid treatments for pain, such as certain bundled payments that make alternative treatment options cost prohibitive for hospitals and doctors, particularly those options for treating immediate post-surgical pain. 20. The Commission recommends a federal effort to strengthen data collection activities enabling real-time surveillance of the opioid crisis at the national, state, local, and tribal levels. 21. The Commission recommends the Federal Government work with the states to develop and implement standardized rigorous drug testing procedures, forensic methods, and use of appropriate toxicology instrumentation in the investigation of drug-related deaths. We do not have sufficiently accurate and systematic data from medical examiners around the country to determine overdose deaths, both in their cause and the actual number of deaths. 22. The Commission recommends reinstituting the Arrestee Drug Abuse Monitoring (ADAM) program and the Drug Abuse Warning Network (DAWN) to improve data collection and provide resources for other promising surveillance systems. 23. The Commission recommends the enhancement of federal sentencing penalties for the trafficking of fentanyl and fentanyl analogues. 24. The Commission recommends that federal law enforcement agencies expressly target Drug Trafficking Organizations and other individuals who produce and sell counterfeit pills, including through the internet. 25. The Commission recommends that the Administration work with Congress to amend the law to give the DEA the authority to regulate the use of pill presses/tableting machines with requirements for the maintenance of records, inspections for verifying location and stated use, and security provisions. 26. The Commission recommends U.S. Customs and Border Protection (CBP) and the U.S. Postal Inspection Service (USPIS) use additional technologies and drug detection canines to expand efforts to intercept fentanyl (and other synthetic opioids) in envelopes and packages at international mail processing distribution centers. 27. The Commission recommends Congress and the Federal Government use advanced electronic data on international shipments from high-risk areas to identify international suppliers and their U.S.-based distributors.

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28. The Commission recommends support of the Synthetics Trafficking and Overdose Prevention (STOP) Act and recommends the Federal Government work with the international community to implement the STOP Act in accordance with international laws and treaties. 29. The Commission recommends a coordinated federal/DEA effort to prevent, monitor and detect the diversion of prescription opioids, including licit fentanyl, for illicit distribution or use. 30. The Commission recommends the White House develop a national outreach plan for the Fentanyl Safety Recommendations for First Responders. Federal departments and agencies should partner with Governors and state fusion centers to develop and standardize data collection, analytics, and information-sharing related to first responder opioid-intoxication incidents.

Opioid Addiction Treatment, Overdose Reversal, and Recovery 31. The Commission recommends HHS, CMS, Substance Abuse and Mental Health Services Administration, the VA, and other federal agencies incorporate quality measures that address addiction screenings and treatment referrals. There is a great need to ensure that health care providers are screening for SUDs and know how to appropriately counsel, or refer a patient. HHS should review the scientific evidence on the latest OUD and SUD treatment options and collaborate with the U.S. Preventive Services Task Force (USPSTF) on provider recommendations. 32. The Commission recommends the adoption of process, outcome, and prognostic measures of treatment services as presented by the National Outcome Measurement and the American Society of Addiction Medicine (ASAM). Addiction is a chronic relapsing disease of the brain which affects multiple aspects of a person's life. Providers, practitioners, and funders often face challenges in helping individuals achieve positive long-term outcomes without relapse. 33. The Commission recommends HHS/CMS, the Indian Health Service (IHS), Tricare, the DEA, and the VA remove reimbursement and policy barriers to SUD treatment, including those, such as patient limits, that limit access to any forms of FDA-approved medication-assisted treatment (MAT), counseling, inpatient/residential treatment, and other treatment modalities, particularly fail-first protocols and frequent prior authorizations. All primary care providers employed by the above-mentioned health systems should screen for alcohol and drug use and, directly or through referral, provide treatment within 24 to 48 hours. 34. The Commission recommends HHS review and modify rate-setting (including policies that indirectly impact reimbursement) to better cover the true costs of providing SUD treatment, including inpatient psychiatric facility rates and outpatient provider rates. 35. Because the Department of Labor (DOL) regulates health care coverage provided by many large employers, the Commission recommends that Congress provide DOL increased authority to levy monetary penalties on insurers and funders, and permit DOL to launch investigations of health insurers independently for parity violations. 36. The Commission recommends that federal and state regulators should use a standardized tool that requires health plans to document and disclose their compliance strategies for nonquantitative treatment limitations (NQTL) parity. NQTLs include stringent prior authorization 15

and medical necessity requirements. HHS, in consultation with DOL and Treasury, should review clinical guidelines and standards to support NQTL parity requirements. Private sector insurers, including employers, should review rate-setting strategies and revise rates when necessary to increase their network of addiction treatment professionals. 37. The Commission recommends the National Institute on Corrections (NIC), the Bureau of Justice Assistance (BJA), the Substance Abuse and Mental Health Services Administration (SAMHSA), and other national, state, local, and tribal stakeholders use medication-assisted treatment (MAT) with pre-trial detainees and continuing treatment upon release. 38. The Commission recommends DOJ broadly establish federal drug courts within the federal district court system in all 93 federal judicial districts. States, local units of government, and Indian tribal governments should apply for drug court grants established by 34 U.S.C. § 10611. Individuals with an SUD who violate probation terms with substance use should be diverted into drug court, rather than prison. 39. The Commission recommends the Federal Government partner with appropriate hospital and recovery organizations to expand the use of recovery coaches, especially in hard-hit areas. Insurance companies, federal health systems, and state payers should expand programs for hospital and primary case-based SUD treatment and referral services. Recovery coach programs have been extraordinarily effective in states that have them to help direct patients in crisis to appropriate treatment. Addiction and recovery specialists can also work with patients through technology and telemedicine, to expand their reach to underserved areas. 40. The Commission recommends the Health Resources and Services Administration (HRSA) prioritize addiction treatment knowledge across all health disciplines. Adequate resources are needed to recruit and increase the number of addiction-trained psychiatrists and other physicians, nurses, psychologists, social workers, physician assistants, and community health workers and facilitate deployment in needed regions and facilities. 41. The Commission recommends that federal agencies revise regulations and reimbursement policies to allow for SUD treatment via telemedicine. 42. The Commission recommends further use of the National Health Service Corp to supply needed health care workers to states and localities with higher than average opioid use and abuse. 43. The Commission recommends the National Highway Traffic Safety Administration (NHTSA) review its National Emergency Medical Services (EMS) Scope of Practice Model with respect to naloxone, and disseminate best practices for states that may need statutory or regulatory changes to allow Emergency Medical Technicians (EMT) to administer naloxone, including higher doses to account for the rising number of fentanyl overdoses. 44. The Commission recommends HHS implement naloxone co-prescribing pilot programs to confirm initial research and identify best practices. ONDCP should, in coordination with HHS, disseminate a summary of existing research on co-prescribing to stakeholders. 45. The Commission recommends HHS develop new guidance for Emergency Medical Treatment and Labor Act (EMTALA) compliance with regard to treating and stabilizing SUD patients and provide resources to incentivize hospitals to hire appropriate staff for their emergency rooms. 16

46. The Commission recommends that HHS implement guidelines and reimbursement policies for Recovery Support Services, including peer-to-peer programs, jobs and life skills training, supportive housing, and recovery housing. 47. The Commission recommends that HHS, the Substance Abuse and Mental Health Services Administration (SAMHSA), and the Administration on Children, Youth and Families (ACYF) should disseminate best practices for states regarding interventions and strategies to keep families together, when it can be done safely (e.g., using a relative for kinship care). These practices should include utilizing comprehensive family centered approaches and should ensure families have access to drug screening, substance use treatment, and parental support. Further, federal agencies should research promising models for pregnant and post-partum women with SUDs and their newborns, including screenings, treatment interventions, supportive housing, non-pharmacologic interventions for children born with neonatal abstinence syndrome, medication-assisted treatment (MAT) and other recovery supports. 48. The Commission recommends ONDCP, the Substance Abuse and Mental Health Services Administration (SAMHSA), and the Department of Education (DOE) identify successful college recovery programs, including "sober housing" on college campuses, and provide support and technical assistance to increase the number and capacity of high-quality programs to help students in recovery. 49. The Commission recommends that ONDCP, federal partners, including DOL, large employers, employee assistance programs, and recovery support organizations develop best practices on SUDs and the workplace. Employers need information for addressing employee alcohol and drug use, ensure that employees are able to seek help for SUDs through employee assistance programs or other means, supporting health and wellness, including SUD recovery, for employees, and hiring those in recovery. 50. The Commission recommends that ONDCP work with the DOJ, DOL, the National Alliance for Model State Drug Laws, the National Conference of State Legislatures, and other stakeholders to develop model state legislation/regulation for states to decouple felony convictions and eligibility for business/occupational licenses, where appropriate. 51. The Commission recommends that ONDCP, federal agencies, the National Alliance for Recovery Residents (NARR), the National Association of State Alcohol and Drug Abuse Directors (NASADAD), and housing stakeholders should work collaboratively to develop quality standards and best practices for recovery residences, including model state and local policies. These partners should identify barriers (such as zoning restrictions and discrimination against MAT patients) and develop strategies to address these issues.

Research and Development 52. The Commission recommends federal agencies, including HHS (National Institutes of Health, CDC, CMS, FDA, and the Substance Abuse and Mental Health Services Administration), DOJ, the Department of Defense (DOD), the VA, and ONDCP, should engage in a comprehensive review of existing research programs and establish goals for pain management and addiction research (both prevention and treatment).

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53. The Commission recommends Congress and the Federal Government provide additional resources to the National Institute on Drug Abuse (NIDA), the National Institute of Mental Health (NIMH), and National Institute on Alcohol Abuse and Alcoholism (NIAAA) to fund the research areas cited above. NIDA should continue research in concert with the pharmaceutical industry to develop and test innovative medications for SUDs and OUDs, including long-acting injectables, more potent opioid antagonists to reverse overdose, drugs used for detoxification, and opioid vaccines. 54. The Commission recommends further research of Technology-Assisted Monitoring and Treatment for high-risk patients and SUD patients. CMS, FDA, and the United States Preventative Services Task Force (USPSTF) should implement a fast-track review process for any new evidence-based technology supporting SUD prevention and treatments. 55. The Commission recommends that commercial insurers and CMS fast-track creation of Healthcare Common Procedure Coding System (HCPCS) codes for FDA-approved technology-based treatments, digital interventions, and biomarker-based interventions. NIH should develop a means to evaluate behavior modification apps for effectiveness. 56. The Commission recommends that the FDA establish guidelines for post-market surveillance related to diversion, addiction, and other adverse consequences of controlled substances.

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The Drug Addiction and Opioid Crisis The primary goal of the President’s Commission on Combatting Drug Addiction and the Opioid Crisis is to develop an effective set of recommendations for the President to combat the opioid crisis and drug addiction in our nation. Many of the recommendations that follow will require appropriations from Congress into the Public Health Emergency Fund, for block grants to states and to DOJ for enforcement and judicial improvements. It is not the Commission’s charge to quantify the amount of these resources, so we do not do so in this report. The Commission urges Congress to respond to the President’s declaration of a Public Health Emergency and fulfill their constitutionally delegated duty and appropriate sufficient funds to implement the Commission’s recommendations. 175 Americans are dying every day. Congress must act. Notwithstanding this core mission, it is vital to address the influences that transformed the United States into the world leader of opioid prescribing, opioid addiction, and opioid overdose deaths.

Origins of the Current Crisis The Current Crisis. In the mid- to late-19th century, the first national opioid crisis occurred; a detailed history is provided in Appendix 2. During this time, opioid use rose dramatically, fueled by physicians’ unrestrained opioid prescriptions (morphine, laudanum, paregoric, codeine, and heroin) for pain or other ailments, and by liberal use of opioid-based treatments for injuries and diseases impacting Civil War combatants and veterans (see Appendix 2). In parallel with the current crisis, this nation-wide crisis extended across socio-economic statuses, and reached urban and rural areas. This first epidemic was eventually contained and reversed by physicians, pharmacists, medical education, and voluntary restraint, combined with federal regulations and law enforcement. After the first crisis subsided, medical education emphasized the hazards of improper opioid prescribing, and by doing so, created a cultural mindset against the dangers of opioids. However, over 30 years ago, a sequence of events eroded fears of opioids, and the medical community once again relapsed into liberal use of medicinal opioids. Triggered by excessive prescribing of opioids since 1999, the current crisis is being fueled by several factors that did not exist in the 19th century: the advent of large scale production and distribution of pure, potent, orally effective and addictive opioids; the widespread availability of inexpensive and purer illicit heroin; the influx of highly potent fentanyl/fentanyl analogs; the transition of prescription opioid misusers into use of heroin and fentanyl; and the production of illicit opioid pills containing deadly fentanyl(s) made by authentic pill presses. Prescription opioids now affect a wide age range, families both well-off and financially disadvantaged, urban and rural, and all ethnic and racial groups. Historical precedent demonstrated that this crisis can be fought with effective medical education, voluntary or involuntary changes in prescribing practices, and a strong regulatory and enforcement environment. The recommendations of the Commission are grounded in this reality, and benefit from modern systematic epidemiological and large data analytics, evidence-based treatments, and medications to assist in recovery or rescue of an overdose crisis. 19

Contributors to the Current Crisis. A widely held and supportable view is that the modern opioid crisis originated within the healthcare system and have been influenced by several factors: •

Unsubstantiated claims: One early catalyst can be traced to a single letter to the Editor of the New England Journal of Medicine published in 1980, that was then cited by over 600 subsequent articles. 1,2 With the headline “Addiction Rare in Patients Treated with Narcotics,” the flawed conclusion of the five-sentence letter was based on scrutiny of records of hospitalized patients administered an opioid. It offered no information on opioid dose, number of doses, the duration of opioid treatment, whether opioids were consumed after hospital discharge, or long-term follow-up, nor a description of criteria used to designate opioid addiction. Six years later, another problematic study concluded that “opioid maintenance therapy can be a safe, salutary and more humane alternative to the options of surgery or no treatment in those patients with intractable non-malignant pain and no history of drug abuse.” 3 High quality evidence demonstrating that opioids can be used safely for chronic non-terminal pain did not exist at that time. These reports eroded the historical evidence (see Appendix 2) of iatrogenic addiction and aversion to opioids, with the poor-quality evidence that was unfortunately accepted by federal agencies and other oversight organizations.

•

Pain patient advocacy: Advocacy for pain management and/or the use of opioids 4,5,6 by pain patients was promoted, not only by patients, but also by some physicians. One notable physician stated: “make pain ‘visible’… ensure patients a place in the communications loop… assess patient satisfaction; and work with narcotics control authorities to encourage therapeutic opiate use… therapeutic use of opiate analgesics rarely results in addiction.” 7

•

The opioid pharmaceutical manufacturing and supply chain industry: One pharmaceutical company sponsored over 20,000 educational events for physicians and others on managing pain with opioids, claiming their potential for addiction was low. 8 Yet, warning signs of the addictive potential of oxycodone and similar opioids long predated this period: in 1963, Bloomquist wrote that dihydrohydroxycodeinone (oxycodone, Percodan®), “although a useful analgesic retains addiction potential comparable to that of morphine. This fact should be considered when it is prescribed. Because of increasing numbers of addicts to this drug in the State of California, the California Medical Association Committee on Dangerous Drugs and the House of Delegates has recommended that oxycodone-containing drugs be returned to the triplicate prescription list as they were originally in 1949.” This recommendation failed to pass the legislature. 9 Similar warnings followed. Aggressive promotion of an oxycodone brand from 1997-2002 led to a 10-fold rise in prescriptions to treat moderate to severe noncancer pain, and increases in prescribing of other opioids. Subsequently, the highest strengths permissible was increased for opioid-tolerant patients, likely contributing to its misuse. Extended-release (ER) formulations and delayed absorption were marketed as reducing abuse liability, but crushing the pills allowed users to snort or inject the drugs. 10,11 There are now at least five marketed opioids that carry abusedeterrent labeling. It has been hypothesized that the marked rise in heroin and other illicit synthetic opioids is, in part, associated with unintended consequences of reformulation of OxyContin, and a reduced supply and greater expense of prescription opioids. 12,13 To this day, the opioid pharmaceutical industry influences the nation’s response to the crisis.14 For example, during the comment phase of the guideline developed by the Centers for Disease Control and Prevention (CDC) for pain management, opposition to the guideline was more 20

common among organizations with funding from opioid manufacturers than those without funding from the life sciences industry. 15 •

Rogue pharmacies and unethical physician prescribing: The key contributors of the large number of diverted opioids were unrestrained distributors, rogue pharmacies, unethical physicians, and patients whose opioid medications were diverted, or other patients who sold and profited from legitimately prescribed opioids. 16

•

Pain as the ‘fifth vital sign’: The phrase, “pain as the ‘fifth vital sign,’” was initially promoted by the American Pain Society in 1995, to elevate awareness of pain treatment among healthcare professionals; “Vital Signs are taken seriously. If pain were assessed with the same zeal as other vital signs are, it would have a much better chance of being treated properly. We need to train doctors and nurses to treat pain as a vital sign. Quality care means that pain is measured and treated.” 17 The Veteran’s Administration (VA) 18 and then the Joint Commission on Accreditation of Healthcare Organizations (the Joint Commission) designated pain as a ‘fifth vital sign.’19,20 The Joint Commission accredits and certifies health care organizations. Certification has implications for objective assessment of clinical excellence, and for contracting and reimbursement. The Joint Commission’s standards for pain assessment in 2000 “were a bold attempt to address widespread underassessment and undertreatment of pain,” 21 even though the health care community was not advocating for a regulatory approach to pain management. 22 The standards raised concerns that requiring all patients to be screened for the presence of pain and raising pain treatment to patients’ rights issue could lead to overreliance on opioids. The Joint Commission received sponsorship for developing educational materials from an opioid pharmaceutical company, one of over 20,000 pain-related educational programs through direct sponsorship or financial grants. It was “unaware that the science behind their claims and the advice of experts in the field were erroneous.” 23 This designation set in motion a growing compulsion to detect and treat pain, especially to prescribe opioids beyond traditional boundaries of treating acute, postoperative, procedural pain and end-of-life care. The surge in opioid supply escalated into opioid-related misuse, diversion, use disorder, and overdose deaths. Administrators, regulatory bodies, and insurers collectively pressured physicians to address patient satisfaction with aggressive pain management. 24 However, the concept that iatrogenic addiction was rare and that long-acting opioids were less addictive had been widely repeated, and studies refuting these claims were not published until years later. The Joint Commission has since eliminated the requirement that pain be assessed in all patients, except for patients receiving behavioral health care and established much stricter processes to review any corporate sponsorship of educational programs. In 2016, the Joint Commission began to revise its pain standards, 25 which will go into effect in January 2018.

•

Inadequate oversight by the Food and Drug Administration (FDA): The FDA is the sole federal authority responsible for protecting public health by assuring the safety, efficacy, and security of human drugs, biological products, and medical devices. It approves medications to diagnose, treat, and mitigate illnesses, after assessing their safety and efficacy. It safeguards the nation’s medications by setting standards for proper prescribing of approved drugs and post-approval surveillance. The FDA provided inadequate regulatory oversight. Even when overdose deaths mounted and when evidence for safe use in chronic care was substantially lacking, prior to 2001, the FDA accepted claims that newly formulated opioids were not 21

addictive, did not impose clinical trials of sufficient duration to detect addiction, or rigorous post-approval surveillance of adverse events, such as addiction. The FDA also failed to assess the risks associated with deliberate diversion and misuse of opioids, risks that conceivably outweighed the intended benefits for patients if used as directed. They accepted the pharmaceutical industry’s claim that iatrogenic addiction was “very rare” and that the delayed absorption of OxyContin reduced the abuse liability of the drug. 26 By 2001, the FDA removed these unsubstantiated claims from OxyContin’s labeling. In March 2016, the FDA requested from the National Academies of Sciences, Engineering, and Medicine (NASEM) and received on July 13, 2017, a summary of the current status of science regarding prescription opioid abuse and misuse, and the role of opioids in pain management. 27 The current FDA Commissioner has stated a strong commitment to using the regulatory authority of the FDA to mitigate the adverse consequences of opioid use. 28 •

Reimbursement for prescription opioids by health care insurers: Sales of prescription opioids in the U.S. nearly quadrupled from 1999 to 2014, 29 largely paid for by insurance carriers. It is estimated that 1 out of 5 patients with non-cancer pain or pain-related diagnoses are prescribed opioids in office-based settings. 30 From 2007 to 2012, the rate of opioid prescribing steadily increased amongst specialists more likely to manage acute and chronic pain (pain medicine [49%], surgery [37%], physical medicine/rehabilitation [36%]). Insurance carriers, including Medicare Part D plans, did not serve as a stop-gap to the huge influx of opioid prescriptions.

•

Medical education: Medical education has been deficient in pain management, opioid prescribing, screening for, and treating addictions. 31 During the 1990’s, the pain movement should have alerted medical education institutions and creators of continuing medical education courses to address this issue. In some medical schools and some specialties, it remains inadequate to this day. 32 One strategy promoted 10 years ago to stratify patients’ risk for opioid misuse and overdose was the screening of patients for substance use disorders (SUDs), especially pain patients. 33 Implementation of Screening, Brief Interventions, and Referral to Treatment (SBIRT) in healthcare systems was incentivized with billing codes. 34 SBIRT was mainstreamed into health care reform, but has yet to be incorporated nationally into medical curricula, or applied as routine care. Nor do core curricula necessarily address addictions, treatment options, or stress the need to screen for substance use and mental health.

•

Lack of patient education: Patients and their families are not often fully informed regarding whether their prescriptions are opioids, the risks of opioid addiction or overdose, control and diversion, dose escalation, or use with alcohol or benzodiazepines.

•

Public demand evolves into reimbursement and physician quality ratings pegged to patient satisfaction scores: Today, the use of opioids for chronic non-cancer pain remains controversial for the same reasons their use declined and was avoided at the turn of the 20th century: the potential for misuse and addiction, insufficient high-quality evidence of efficacy with long-term use, poor functional outcomes, overdose and death. Yet, a strong public demand for opioids continues to pressure clinicians to prescribe opioids persists. As an example, a recent survey of Emergency Department (ED) physicians indicated that 71% reported a perceived pressure to prescribe opioid analgesics to avoid administrative and regulatory criticism. Uniformly, they voiced concern about excessive emphasis on patient satisfaction scores by reimbursement entities as a means of evaluating their patient 22

management. The physician requirement to address pain as the "fifth vital sign" persists, 35 and reimbursement metrics based on patient satisfaction may have inadvertently created an environment conducive to exploitation by prescription opioid abusers. 36 There are legitimate circumstances for which opioids are an appropriate therapy. But many current institutional and societal issues continue to pressure physicians to prescribe opioids when they are not clinically appropriate. Prior to this year, poor patient satisfaction with pain care could lead to reduced hospital reimbursement by Medicare through Value-Based Purchasing (VBP). There are often higher costs or no specific reimbursements for alternative pain management strategies, alternative pain intervention strategies, or spending time to educate patients about the risks of opioids. Further, failing to provide adequate pain relief can be grounds for malpractice claims or medical board action. •

Lack of foresight of unintended consequences: As prescription drugs came under tighter scrutiny and access became more limited (via abuse-deterrent formulations and more cautious prescribing), market forces responded by providing less expensive and more accessible illicit opioids. Increases in overdose death numbers due to prescription opioids have transitioned to overdoses largely due to heroin and, increasingly, fentanyl. 37 Locally, this trend may have been driven, in part, by tightening controls on prescription opioids. Physicians curtailed opioid prescriptions without guidelines on tapering and without determination of whether patients had developed an opioid use disorder (OUD), and if so, how to respond. 38 The availability of cheaper heroin also drove prescription opioid misusers to illicit opioids. Black market heroin is currently much less expensive than diverted prescription opioids, and fentanyl is even much less expensive per dose than heroin. Predictable from the economics of the two drug categories, the prescription drug overdose problem has decreased, but not the overall number of opioid-related deaths.

•

Treatment services insufficient to meet demand and to provide medication-assisted treatment (MAT): As OUDs increased dramatically over the past 15 years, quality treatment services and the associated workforce did not expand in response to the growing crisis.

•

Lack of national prevention strategies: Prevention strategies focusing on specific illicit drugs for vulnerable populations - adolescents, college age youth, pregnant women, unemployed men, and other - and for influencers, (parents, families) don’t exist or have not been tested adequately.

Magnitude and Demographics National statistics on prescription opioid misuse and use disorder, 2016. 39 Weighted National Survey on Drug Use and Health (NSDUH) estimates suggested that, in 2016, 91.8 million (34.1%) or more than one-third of U.S. civilian, noninstitutionalized adults used prescription opioids; 11.5 million (4.3%) misused them. In 2015, 1.6 million (0.7%) had an OUD. Among adults with prescription opioid use, 12.2% reported misuse and 15.1% of misusers reported a prescription OUD. 40 The most commonly reported motivation for misuse was to relieve physical pain (63.6%). Misuse and use disorders were most commonly reported in adults who were uninsured, were 23

unemployed, had low income, or had behavioral health problems. Among adults with misuse, 62.2% reported using opioids without a prescription, and 40.6% obtained prescription opioids for free from friends or relatives for their most recent episode of misuse. The results suggest a need to improve access to evidence-based pain management and to decrease excessive prescribing that may leave unused opioids available for potential misuse. 41 The NSDUH estimates that 3.4 million people aged 12 or older in 2016 were current misusers of pain relievers (1.2% of the population aged 12 or older). 42 In 2016, an estimated 239,000 adolescents aged 12 to 17 were current misusers of pain relievers (1.0% of adolescents) and 631,000 young adults aged 18 to 25 misused pain relievers in the past month (1.8% of young adults). Among adults aged 26 or older, 2.5 million are estimated to be current misusers of pain reliever (1.2%). Upwards of 1.8 million Americans harbor an OUD involving prescription opioids or 0.7% of people aged 12 or older. Among adolescents aged 12 to 17, 152,000 (0.6%) had a pain reliever use disorder in the past year, and 291,000 young adults aged 18 to 25 (0.8%) and 1.3 million adults aged 26 or older in 2016 (0.6%) had a pain reliever use disorder in the past year. These small percentages do not convey the massive personal and public health burden created by misuse of opioids. National statistics on heroin use and use disorder, 2016. 43 The addictive and illegal opioid heroin has no accepted medical use in the United States. Past 30 day users of heroin (475,000) among people aged 12 or older or 0.2% of the population is probably an underestimate because NSDUH surveys households and does not capture heroin users in homeless shelters or transient populations with no fixed address, and the incarcerated. Despite its dangers heroin use continues to escalate and reflects changes in heroin use by adults aged 26 or older and, to a lesser extent, among young adults aged 18 to 25. Less than 0.1% of adolescents aged 12 to 17 were current or past year heroin users (3,000 and 13,000, respectively) and these numbers remained relatively stable. Among young adults aged 18 to 25, 0.3% were current heroin users (88,000) and this number rose since 2002. For past year and at minimum, 630,000 individuals have a heroin use disorder (HUD).17 Among adults 26 and older 0.2% were current heroin users (383,000), a rise since 2015. About 626,000 people aged 12 or older reported an HUD (0.2%), an increase since 2002 to 2011. Less than 0.1% of adolescents aged 12 to 17 (1,000) had an HUD in the past year, but this rate was many times higher among 18-25-year-olds (152,000; 0.4%). Approximately 473,000 adults aged 26 or older had an HUD (0.2%) Substance use disorder treatment needs, 2016. 44 For NSDUH, people are defined as needing substance use treatment if they had an SUD in the past year or if they received substance use treatment at a specialty facility in the past year. In 2016, 10.6% of people aged 12 or older (2.3 million people) who needed substance use treatment received treatment at a specialty facility in the past year. Among people in specific age groups needing substance use treatment, 8.2% of adolescents aged 12 to 17, 7.2% of young adults aged 18 to 25, and 12.1% of adults aged 26 or older received substance use treatment at a specialty facility in the past year. These percentages represent 89,000 adolescents, 383,000 young adults, and 1.8 million adults aged 26 or older who needed substance use treatment and received treatment at a specialty facility in the past year. Prior to 2016, NSDUH reported on the reasons people in need in treatment did not receive it. Approximately 90% self-reported they did not feel the need for treatment and did not seek it. Special Populations. The Commission recognizes that, although many of the recommendations included in this report are generic for the population as a whole, subpopulations exist within our nation that conceivably require increased outreach, access to services, and more tailored or 24

intensive services. These special populations can be viewed from the perspective of race or ethnicity, residential location and population density, gender, age 45, mental 46 and physical health status (e.g. HIV-AIDS), income, employment, socio-economic status, education, veterans, 47,48 involvement in the criminal justice system (juveniles, parolees, incarcerated), family status (fetus 49, children of substance-using parents or other family members, pregnant women, living alone), healthcare insurance sources, behavioral health indicators 50 (other SUDs or history), type of opioid use (heroin/fentanyl, prescription opioid nonmedical or medical use, or combined use), and others. According to the 2016 NSDUH, more males (4.8%) than females (3.8%) misused prescription opioid medications. 51 Young adults aged 18 to 25 years old had the largest proportion of misusers. In comparison to the national average for past year misuse of pain relievers by those 12 years and older, misuse was most common among Americans with two or more races (6.5%), American Indian or Alaska Natives (3.9%), Native Hawaiian or other Pacific Islanders (4.2%), and Hispanics (4.2%). The rate of non-medical use of prescription opioid medications was lowest among Asians (1.8%). Scrutiny of the NSDUH and other data sources can reveal which populations are at highest risk. A recent study using 2010-2013 NSDUH data 52 revealed the prevalence of OUDs was highest among whites (72.29%), with lower prevalence among blacks (9.23%), Hispanics 13.82%, and others 4.66%. Other factors overrepresented among those reporting OUDs were adults aged 18–34 (55.95%), males (57.39%), low income (